Stress urinary incontinence (SUI) is a common condition and is characterized as the involuntary leakage of urine on effort, exertion, sneezing or coughing. (Abrams P, et al. Neurourol Urodyn 2002; 21(2): 167-178). The etiology of SUI is multifactorial, involving damage and/or functional impairment of muscle and associated nerves that may occur as a result of advancing age, hormonal status, and pelvic floor damage resulting from vaginal child-birth. Due to the multifactorial etiology, a single treatment option, that is not limited in some fashion, does not currently exist.
The use of periurethral injectables as a minimally invasive treatment option, which may be performed on an outpatient basis under local anesthesia. This method of treatment is more cost effective in the near-term, with shorter hospitalization, reduced operating room time, and generally fewer complications when compared with invasive surgical approaches such as bladder neck suspension. (Berman C J, et al. J Urol 1997; 157(1): 122-124). However, it has disadvantages such as need for multiple injections due to loss of the long-term bulking effect owing to degradation, reabsorption, and/or migration, as well as other impediments such as bladder outlet obstruction and allergic reactions. Thus, there is a need for other, different urinary augmentation materials that are long-lasting, compatible with a wide range of host tissues, and which cause minimal inflammation, scarring, and/or stiffening of the tissues surrounding the implant site.
Muscle derived cells isolated from rats have shown some success models for urinary incontinence. (Cannon T W, et al. Urology 2003; 62(5): 958-963 and Lee J Y et al. Int Urogynecol J Pelvic Floor Dysfunct 2003; 14(1): 31-37; discussion 37). The instant invention provides the use of human skeletal muscle derived cells (MDC) as an injectable treatment for SUI, and other urinary tract pathologies.